Clark J. Kashmaier 971-217-5558 firstname.lastname@example.org
The FDA issued "regulations that provide criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper." (page 13420 of the Federal Register/Volume 62, No. 54/Thursday, March 20, 1997/Rules and Regulations)
While the actual regulations are reasonably short, the issuance of these regulations has caused significant action and concern by those who fall under the jurisdiction of FDA regulations.
In 2003, a Guidance for Industry Part 11, Electronic Records; Electronic Signatures -- Scope and Application was issued by the FDA, in which (on lines 178-181) it states: "Records that are required to be maintained under predicate rule requirements and that are maintained in electronic format in place of paper format [fall under Part 11]. On the other hand, records (and any associated signatures) that are not required to be retained under predicate rules, but are nonetheless maintained in electronic format, are not part 11 records."